DeBeurs.nl

Ferdinand 62 25 september 2020 09:19

0

Eindelijk weer eens goed nieuws voor Genfit. Hopen dat de koers nu weer flink gaat stijgen. Het bedrijf heeft een enorme kaspositie dus dat is niet iets om je zorgen over te maken.

Genfit: eerste bezoek voor een proef in het PBC
CERCLE FINANCE • 25/09/2020 om 08:09 uur
(CercleFinance.com) - Het biofarmaceutische laboratorium Genfit kondigt aan dat het het eerste bezoek heeft gebracht van de eerste patiënt voor ELATIVE, de internationale cruciale fase III klinische studie die elafibranor bij primaire biliaire cholangitis (PBC) evalueert.

PBC beïnvloedt en vernietigt geleidelijk de galwegen, waardoor ontstekingen en schade aan de lever ontstaan. Deze pathologie kan leiden tot cirrose, leverfalen en kan uiteindelijk een levertransplantatie vereisen.

'Er is tot op heden geen remedie voor PBC, en momenteel beschikbare therapieën zijn alleen in staat om de progressie van de ziekte mogelijk te vertragen', zegt Genfit.

DeZwarteRidder 25 september 2020 09:48

1

quote:
RW1963 schreef op 21 september 2020 16:27:
[...]Als ik zo teruglees was je in mei nog zeer negatief over dit aandeel. Dus je bent bijgedraaid?

Ik was zeer negatief over hun NASH-middel en de koers was toen nog veel te hoog.

Inmiddels is de situatie totaal anders geworden, mede dankzij een grote verkoper die koste wat het kost van z'n aandelen af wilde.

DeZwarteRidder 28 september 2020 09:11

0

Alles vliegt omhoog, Genfit zelfs met 20%.............!!

Ferdinand 62 28 september 2020 10:16

0

De stijging komt door onderstaand bericht. Vorige week al goed nieuws en nu weer.
Fijn voor iedereen die er nog in zit. Heb ze zelf al een tijdje niet meer.

GENFIT en LabCorp ondertekenen een exclusieve overeenkomst
AOF • 28/09/2020 om 08:32 uur
(AOF) - Genfit en LabCorp hebben de ondertekening aangekondigd van een exclusieve licentieovereenkomst voor vijf jaar voor GENFIT's NIS4 (TM) -technologie om de identificatie van risicovolle NASH-patiënten te vergemakkelijken. Volgens de voorwaarden van de overeenkomst zal LabCorp een bloedmoleculaire diagnostische test op basis van NIS4 (TM) -technologie op de markt brengen in de Verenigde Staten en Canada, waardoor de toegang tot gezondheidswerkers wordt verruimd.

Hulskof 28 september 2020 10:58

2

Toch weer goed gezien van DZR. Plus 43%. Leuke daghandel.

RW1963 28 september 2020 11:38

0

quote:
Hulskof schreef op 28 september 2020 10:58:
Toch weer goed gezien van DZR. Plus 43%. Leuke daghandel.

Ben ze kwijt met winst.
Jammer dat ik er niet veel had.

DeZwarteRidder 1 oktober 2020 10:23

0

GENFIT: First Half-Year 2020 Financial Report and New Corporate Strategy
September 30, 2020
PDF Version

Cash position of €226 million at June 30, 2020 (€277 million at December 31, 2019)

New Corporate strategy focused on two priority areas:
Development of elafibranor in Primary Biliary Cholangitis (PBC): ongoing enrolment for Phase 3 clinical trial ELATIVE™
Commercialization of NIS4™ for NASH diagnosis: exclusive licensing agreement with Labcorp
Plan to create two GENFIT SA subsidiaries by 2021, to facilitate decision-making and enable an independent management and growth
Corporate restructuring plan to reprioritize capital for essential operating activities. Objective of cash burn reduction by more than 50% by 2022:
Termination of elafibranor’s clinical development in NASH
Termination of all activities associated with elafibranor’s launch preparations in NASH
Reallocation of our research program to focus efforts on key programs
Comprehensive cost-saving plan and restructuring plan, with a 40% workforce reduction in the Group

Lille, France; Cambridge, MA; September 30, 2020 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced its first half-year 2020 financial report, including the advances of its R&D portfolio and the new GENFIT corporate strategy. The Half Year Business and Financial Report, including the new corporate strategy is available to the public and was filed with the French Autorité des marchés financiers (French Financial Markets Authority) today. The condensed consolidated financial statements are included in this press release and the complete financial statements are available on the “Investors” page of the GENFIT website.

Conference Call in English on September 30, 2020 at 4:30pm EDT / 22:30 CEST, and in French on October 1, 2020 at 1:30am EDT / 7:30am CEST

Both the English and French conference calls will be accessible on the investor page of our website, under the events section at ir.genfit.com/ or by calling 877-407-9167 (toll-free U.S. and Canada), 201-493-6754 (international) or 0 800 912 848 (France) five minutes prior to the start time (no passcode needed). A replay will be available shortly after the call.

New corporate strategy and prospects

The company’s corporate strategy now focuses on two priority areas:

Phase 3 clinical trial ELATIVE™ evaluating elafibranor in PBC:
Patient enrolment now started, and results expected early 2023, given the current constraints due to the COVID-19 pandemic;
Following the positive Phase 2 data of elafibranor in PBC, the U.S. Food and Drug Administration (FDA) granted elafibranor Breakthrough Therapy designation. The ELATIVE™ study aims to confirm elafibranor’s previously successful results of efficacy, potential improvement in pruritus and safety in PBC patients;
Current market size for second line therapies in PBC is estimated at ~ $300MM in 2020 and is anticipated to experience double digit growth and estimates for 2025 are up to $1B. Elafibranor is a promising alternative therapy to the existing treatment in PBC, based on the significant unmet needs in this indication.

NIS4TM technology for (NASH) diagnosis:
NIS4TM technology data, recently published in The Lancet Gastroenterology & Hepatology, confirmed the technology’s diagnostic performance and garnered the support of leading NASH experts;
The recently announced exclusive licensing agreement with Labcorp for NIS4 TM technology will enable a large-scale commercial launch as of next year;
NIS4TM addresses patients’ and payers’ requirements as liver biopsy remains the only – although imperfect – approved diagnostic option in the clinical development field and cannot be replicated on a large scale due to its painful and invasive nature, and its cost for healthcare systems. It would be impossible to diagnose all patients with biopsies given the limited number of procedures that can be performed. The blood test commercialized by Lacorp will address these multiple challenges;
The NASH therapeutic market is potentially significant, however, the opportunity is dependent on quick, reliable and easy to execute diagnostic solutions to identify patients. NIS4TM technology represents the essential first step in managing patients with NASH and is the first step for patients to take control, even in the absence of treatments, of their disease.

GENFIT’s new strategy includes a plan, which aims to create two distinct operational subsidiaries by 2021 to enable more independent management and growth:

The first entity would be dedicated to the development of specialty indications, starting with the Phase 3 trial in PBC;

The second entity would house NASH solutions, including all programs related to the identification, evaluation and monitoring of patients with NASH. This independent structure would facilitate future partnerships for NIS4™.

The two entities would remain a part of GENFIT as a listed company, who would ensure adequate decision making between both “business” entities, the goal being to best highlight each of the activities to benefit the Group’s valuation.

Concurrently, GENFIT is adopting a plan to reallocate and rationalize all capital with an objective to reduce the cash burn by more than 50% by 2022 compared to our cash burn prior to the RESOLVE-IT Phase 3 data. The program aims to reduce the current cash burn rate from €110M annually before our Phase 3 data, to approximately €45MM annually, beginning in 2022. Due to the residual expenses related to the termination of RESOLVE-IT, 2021 will be a transition year.

This plan incorporates the following key components:

The overall clinical development program for elafibranor in NASH and all activities associated with the commercial launch of elafibranor in NASH have been terminated given the low probability of success compared to required expenses. The termination includes the NASH combination therapy trials, the pediatric trials, and other trials such as the evaluation of the impact of elafibranor on liver fat composition;

A comprehensive cost-saving plan has been implemented, including the redirection of R&D activities and the termination of secondary programs (i.e. the RORgT program);

A workforce restructuring plan aims to reduce the overall workforce by 40%, encompassing both the U.S and France in order to align the company size to the new scope of activity.

Lastly, GENFIT plans to propose to the holders of its OCEANE bond (€180 million nominal amount with a maturity of October 16, 2022) and its shareholders, an adjustment of the terms of the OCEANE convertible bond. The Company's objective is to begin this process towards the end of the year, in order to have a balance sheet which is structured in line with its new strategy.

Pascal Prigent, CEO of GENFIT, stated: “The decisions we have taken allow us to move GENFIT forward towards 2021 with a clear and precise roadmap. We are confident in the probability of success, and the potential of our two priority programs. The evolution of the company also ensures the structure adapts to our strategy, with an approach that is both organizationally and financially sound.”

Hulskof 1 oktober 2020 11:44

0

Klinkt op zich niet verkeerd, al moet die NASH-test dan wel ergens volgend jaar de markt op om een nieuwe emissie te vermijden. Immers, 2021 overgangsjaar. Gemakshalve ga ik ervan uit dat er dan zo'n 100 miljoen op is. Blijft er nog zo'n 60 miljoen over, mogelijk net genoeg voor nog een jaartje.
Misschien wat mager om je bestaan tot 2024 (2023 P3 verwacht) te laten afhangen van alleen een NASH-test? Hoeveel denken ze daarmee te gaan binnenhalen?

Lingus 1 oktober 2020 19:57

0

www.biopharmadive.com/news/genfit-lay...

DeZwarteRidder 11 november 2020 13:23

0

Genfit gisteren en vandaag flink omhoog.

[verwijderd] 27 november 2020 09:18

0

En opnieuw!

DeZwarteRidder 27 november 2020 09:34

0

quote:
Opus135 schreef op 27 november 2020 09:18:
En opnieuw!

5 euro gezien!

[verwijderd] 30 november 2020 10:35

0

quote:
DeZwarteRidder schreef op 27 november 2020 09:34:
[...]
5 euro gezien!

Its happening again.
Hopelijk geen terugval als vrijdag namiddag

Vertraagd	18 apr 2024 17:35
Koers	3,185
Verschil	+0,010 (+0,31%)
Hoog	3,210
Laag	3,160
Volume	41.398
Volume gemiddeld	154.775
Volume gisteren	47.906

Genfit « Terug naar discussie overzicht

Genfit 2020

Meedoen aan de discussie?

Direct naar Forum

Detail

Genfit nieuws meer